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RI Quality Engineer
Experience Required :
- To perform this job successfully, an individual must have the necessary knowledge on Manufacturing process and quality topics.
- The requirements listed below are representative of the knowledge, skill, and/or ability required:
- Experience in Component Inspection and documentations, standard Work instructions for commodities such as printed circuit board assemblies, power supplies, cables, custom battery packs, mechanical parts (plastics, machined, sheet metal), cables, etc..
- Experience in SAP and Data Management.
- Experience in regulated industry, Medical preferred
- Knowledge of FDA standards such as 21 CFR Part 820, 21 CFR Part 11, ISO 13485, etc.,
- Good teamwork skills, can work independently, not afraid to speak up, and works well with others
Keywords:
Medical Devices, Component Inspection, CTQ, CoC, CoA, SAP, Writing Inspection Plans, Components Acceptance Activities ,Assembly Line inspection experience,
Primary Skills:
- Experience in Medical / Aerospace / Automotive Manufacturing quality process
- Experience in Inspection of electro mechanical commodities
Secondary Skills
Process Documentation, Plant Quality Measures & Remediation Activites of medical devices